A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer

Phase 2

Completed

• Conditions: Neoplasms, Ovarian; Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
• Interventions: Drug: GW786034

• Registration Number: NCT00281632
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-01-23
• Study First Submitted QC: 2006-01-23
• Study First Posted: 2006-01-25
• Study Start: 2006-03
• Primary Completion: 2008-04
• Results First Submitted: 2009-11-25
• Study Completion: 2010-10
• Results First Submitted QC: 2011-01-03
• Results First Posted: 2011-01-04
• Status Verified: 2011-02
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pazopanib	GW786034	800 mg GW786034 administered orally on a daily basis.

Primary Outcome Measures

Name	Time	Method
Best Biochemical Response (Cancer Antigen [CA-125])	Baseline to response (up to 3 years)	Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 \>21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir \>21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure	Baseline to response (up to 3 years)	Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.
Overall Tumor Response	Baseline to response (up to 3 years)	Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.
Time to Biochemical Response (CA-125)	Baseline to response (up to 3 years)	Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.
Overall Response and Stable Disease (SD)	Baseline to response (up to 3 years)	Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.
Duration of Biochemical Response (CA-125)	Baseline to response (up to 3 years)	Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.
CA-125 Doubling Time Prior to and During Treatment With Pazopanib	Baseline to doubling of CA-125 (up to 3 years)	CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.
Mean Change From Baseline to Response in Amylase and Lipase	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Median Progression-free Survival (PFS)	Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)	Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.
Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure	Baseline to response (up to 3 years)	Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate	Baseline to response (up to 3 years)	Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.
Mean Change From Baseline to Response in Albumin	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Mean Change From Baseline to Response in Thyroid Stimulating Hormone	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Mean Change From Baseline to Response in Total Bilirubin and Creatinine	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Mean Change From Baseline to Response in Thyroxine	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Mean Change From Baseline to Response in Hemoglobin and Hematocrit	Baseline to response (up to 3 years)	Change from baseline is calculated as the value at the time of response minus the value at Baseline.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇬 Singapore, Singapore